To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.

For details on how to find us please click here.

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What's New in eSubmission Today?

05-12-2024

EU Harmonised technical eCTD guidance version 6.0 now available

A new updated version of the eCTD EU Harmonised technical guidance is now available here, together with the Release notes.

The EU Harmonised technical guidance is aligned with the EU M1 eCTD Specification v3.1 and the Validation Criteria v8.1.

The timeline for implementation is as follows:

• (optional use): From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1 or v8.1 are accepted.
• (mandatory use): From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.1 are accepted.

And

Updated version of the VNeeS specification v3.2 now available

The guideline on eSubmissions for Veterinary products version 3.2 has now been published. It will enter into force on 1 January 2025 (see links under section "Current Guidance" below).

The update is related to text changes only (detailed in the release notes for version 3.2) and it does not affect the validation criteria.

And

Updated VNeeS Q&A relating to eSubmission for Veterinary Applications now available

The VNeeS Q&A relating to eSubmission for Veterinary Applications was updated and it can be found in the Current Guidance section.

04-12-2024

Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5 December 2024, between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common Repository Web-UI and API, PSUR Repository Web-UI (both NCA and industry access) and API.

The maintenance includes various improvements and implementations:

• Common Repository Web-UI - technology modernisation
• Gateway XML delivery file user interface - various improvements and integrations for retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
• Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g. renaming of the submission mode from "IG" to "super-grouping")

Updated documentation will be published on the relevant pages of the eSubmission website. For any further information, please contact EMA Service Desk.

03-12-2024

Call for Interest eCTD v4.0 Technical Pilot

The electronic Common Technical Document (eCTD) v4.0 is pleased to announce the launch of the eCTD v4.0 Technical Pilot and invite interested eCTD tool vendors to participate in Step 1. A call for participation in the following steps will be launched at a later stage.

If you have not yet expressed your interest, please send an email to eCTD4consultation@ema.europa.eu by 20 December 2024 to express your intention to participate. If approved, you will receive a confirmation e-mail with further instructions.

Step 1

• Participants: Tool vendors, EMA
• Timeline: Q4 2024 - Q1 2025
• Focus Area: Technical Interoperability

• Participants: Tool vendors (potential collaboration with MAHs), EMA
• Timeline: Q1 2025 (Subject to finalisation of step 1) - TBD
• Focus Areas:
• Simple scenarios (mock submissions, single package/sequence)
• Document lifecycle management (e.g. replacements, updates)
• Handling of multiple file formats, pack sizes, manufacturers
• Review of controlled vocabularies (CV)
• Updating keywords, priority numbers, and document titles
• Document reuse

• Participants: Tool vendors, MAHs, EMA
• Timeline: Subject to finalisation of step 2, TBD
• Focus Areas:
• Expansion of Step 2 scenarios with non-mock data
• Grouped submissions functionality, forward compatibility
• Parallel regulatory activities

PFor a high-level view, please refer to the attached pilot plan.

02-12-2024

Updated eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025

An updated/corrected version of the eAF 1.27.0.0 (Human variation) is now available on the eSubmission website. The difference compared to the version published on the 27^th of November is in the exported XML, which now correctly contains the super-grouping checkbox.

It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start date after 1^st of January 2025.

The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for procedures starting until 31 December 2024. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Please note that in case you need to provide an update to a form that has been submitted prior to 1^st of January 2025, you should use the previous version (1.26.0.0).

27-11-2024

EMA encourages companies to submit type I variations for 2024 by end November 2024

EMA is advising marketing authorisation holders to submit type IA and type IA_IN variations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 20 December 2024 and 5 January 2025, within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2024 for a start of procedure in 2024. For submissions received on or after 1 December 2024, the procedure may not start until January 2025.

and

eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025

In line with the amended Variation Regulation entering into force on the 1^st of January 2025 ( Guidance on the application of the amended Variations Regulation from 1 January 2025 | European Medicines Agency (EMA) ), a new version of the Human Variation eAF v1.27.0.0 is now available on the eAF website.

It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start date after 1^st of January 2025.

The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for procedures starting until 31 December 2024. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Please note that in case you need to provide an update to a form that has been submitted prior to 1^st of January 2025, you should use the previous version (1.26.0.0).

The form, the release notes and the associated files (i.e. schema and dictionary) are published in the relevant sections of the eAF webpage.

26-11-2024

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.0.3 released to production on 25 November 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

18-11-2024

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.0.2 released to production on 11 November 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

30-10-2024

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.0.1 released to production on 28 October 2024 are now available on PLM Portal and on the PLM Portal eAF web page.

29-10-2024

Interactive PDF eAF technical documentation updated

An updated set of schemas were published under the "Technical Documents" section of eAF (interactive PDF), relevant for small changes in the XML schema definition for versions 1.26.0.0 and 1.26.0.1. The changes are reflected in the "eAF DES change summary" document.

28-10-2024

Minor update to the published EU Validation criteria

An updated version of the validation criteria to add further clarification the has been published on the eSubmission website. The version is related to the EU Module 1 Specification version 3.1 and should be used in case of submitting a new sequence according to EU M1 specification v3.1. The new validation criteria will be used for the technical validation for all v3.1 electronic submissions received as of 1 March 2025 to the NCAs and EMA. The changes are reflected in the Release Notes.

From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1, 8.0 or v8.1 are accepted.

From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.1 are accepted.

24-10-2024

Planned maintenance of eSubmission systems on 24 October 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Thursday 23 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository XML delivery file UI (relevant for industry only).

Previously created delivery files will continue to work. For any further information, please contact EMA Service Desk.

14-10-2024

Non-Centrally Authorised Products now available in the PLM Portal eAF

The EMA is pleased to announce that the non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.

Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations containing CAPs and non-CAPs.

Please join the training session on 17 October 2024 10:00 - 11:30 (CEST).

Please see an updated version of the draft PLM Portal eAF guide to navigation is now available.

04-10-2024

EU eCTD v4.0 draft Implementation package now available

An updated draft version of the EU eCTD v4.0 implementation package is now available here.

The package contains the following:

• EU eCTD v4.0 Implementation Guide draft version 1.2 ; this version is focused on CAPs and the main changes since version 1.1 are reflected in the "Document change history" of the file
• EU eCTD v4.0 Controlled Vocabularies, in .xlsx format (version 1); the genericode files (.xml format) will be published in the following weeks
• EU eCTD v4.0 Accepted file formats